NCT01398020

Brief Summary

The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

1.2 years

First QC Date

July 14, 2011

Last Update Submit

September 17, 2013

Conditions

Efficacy of Bowel PreparationEase of Bowel Preparation and Patient Tolerability

Keywords

Bowel PreparationPatient comfortBi-Peglyte

Outcome Measures

Primary Outcomes (1)

  • Difference in Boston Bowel Preparation Scale between the two groups

    This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.

    30 minutes

Secondary Outcomes (2)

  • Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups

    20 hours

  • Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.

    20

Study Arms (2)

Standard bowel prep

ACTIVE COMPARATOR

Subject will receive standard bowel prep prior to colonoscopy.

Drug: Standard Bowel Prep

2L Bi-Peglyte

EXPERIMENTAL

Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy.

Drug: 2L Bi-Peglyte Bowel Prep

Interventions

Standard Bowel PrepDRUG

Subjects will be asked to take 4L of Peglyte the day prior to procedure.

Standard bowel prep
2L Bi-Peglyte Bowel PrepDRUG

Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.

2L Bi-Peglyte

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19 or older
  • Outpatient colonoscopy

You may not qualify if:

  • constipation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

Study Officials

  • Robert A Enns, MD

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 20, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

CA(1)